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Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

NCT01848925 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-12-03

No results posted yet for this study

Summary

The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.

Conditions

Interventions

BIOLOGICAL

SANGUINATE™

40 mg/mL intravenous infusion.

DRUG

Hydroxyurea

Standard of care for Sickle Cell treatment, 15 mg/kg.

Sponsors & Collaborators

  • Prolong Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kenny M Galvez, MD · Hospital Pablo Tobin Uribe

  • Luis F Uribe, MD · Fundacion Reina Isabel

  • Nestor Sosa, MD · Hospital Punta Pacifica

  • Angel Hernandez, MD · Fundacion BIOS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • Colombia
  • Panama

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848925 on ClinicalTrials.gov